| CTRI Number |
CTRI/2024/12/078469 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of two different doses of a vasopressor in pregnant women undergoing elective cesarean section to determine the optimal dose for preventing fall in blood pressure following spinal anesthesia. |
|
Scientific Title of Study
|
Comparison of two different doses of prophylactic Norepinephrine in patients undergoing elective caesarean section to prevent post spinal Anesthesia Hypotension: A Randomised study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devarakonda Sai Manoj |
| Designation |
Junior Resident - Academic |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Dept. of Anesthesiology, All India Institute of Medical Sciences, Bibinagar Hyderabad Metropolitan region
Hyderabad
TELANGANA
508126
India |
| Phone |
9381245396 |
| Fax |
|
| Email |
manojmanoj973@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Dept. of Anesthesiology, All India Institute of Medical Sciences, Bibinagar Hyderabad Metropolitan region
Hyderabad
TELANGANA
508126
India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS BIBINAGAR |
| Address |
Dept. of Anesthesiology, All India Institute of Medical Sciences, Bibinagar Hyderabad Metropolitan region
Hyderabad
TELANGANA
508126
India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Scienes, Bibinagar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Scienes, Bibinagar |
| Address |
All India Institute of Medical Scienes, Bibinagar, Hyderabad Metropolitan Region, Telangana |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devarakonda Sai Manoj |
All India Institute of Medical Scienes, Bibinagar |
Room number G35 and G36, Operation Theater Complex, Department of Anaesthesiology, All India Institute of Medical Scienes, Bibinagar , Hyderabad Metropolitan Region, Telangana- 508126
Hyderabad
TELANGANA |
9381245396
manojmanoj973@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(AIIMS BBN-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High dose vasopressor infusion |
Noradrenaline infusion at the rate of 0.08mcg/kg/min will be used |
| Intervention |
Low dose vasopressor infusion |
Noradrenaline infusion at the rate of 0.04mcg/kg/min will be used |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA II
Uncomplicated normal singleton beyond 36 weeks term pregnancy scheduled for lower segment caesarean section under spinal anesthesia.
|
|
| ExclusionCriteria |
| Details |
BMI more than 40
Multiple gestation
Emergency caesarean
Gestational hypertension
Gestational diabetes mellitus
Cardiovascular, cerebrovascular or renal disease
Oligohydromnios
Intrauterine growth restriction.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of hypotensive episodes between two groups.
|
Till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of rescue boluses, hemodynamic parameters, APGAR score, nausea and vomiting between two groups
|
Hemodynamic parameters till 90mins/end of surgery. Nausea and vomiting are assessed at 3rd,6th,12th and 24th hour.
APGAR scores at 1min and 5min. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prophylactic
infusion of vasopressors with a rescue bolus dosing was observed to be more
effective for hemodynamic stability when compared to administering bolus dose
alone. With norepinephrine 0.04mcg/kg/min, there is decreased incidence(77.9%)
of maternal hypotension. Still 22.1% of the patients were getting
hypotension even with prophylactic norepinephrine infusion at 0.04mcg/kg/min.
so we hypothetise that doubling the dose of norepinephrine prophylactic
infusion can lead to 50% decrease in incidence of hypotension compared to
0.04mcg/kg/min. In this study, we compared two different doses of
norepinephrine 0.04 mcg/kg/min(group A) and 0.08 mcg/kg/min(group B). |